RVP

Drug Catalog - Product Detail

ECONAZOLE NITRATE CREAM 0.01 30GM

NDC Mfr Size Str Form
45802-0466-11 PADAGIS 30 1% CREAM
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PACKAGE FILES

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Generic Name
ECONAZOLE NITRATE
Substance Name
ECONAZOLE NITRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA076479
Description
DESCRIPTION Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol-7 stearate, and purified water. The white to off-white soft cream is for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chlorophenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows: Structural Formula Image
How Supplied
HOW SUPPLIED Econazole Nitrate Cream, 1% is available as follows: 15 g tube (NDC 45802- 466 -35) 30 g tube (NDC 45802- 466 -11) 85 g tube (NDC 45802- 466 -53) Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 11-23 71D00 RC PH2
Indications & Usage
INDICATIONS AND USAGE Econazole Nitrate Cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.
Dosage and Administration
DOSAGE AND ADMINISTRATION Sufficient Econazole Nitrate Cream, 1% should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.